Sr Research and Development Engineer

3 weeks ago

Irvine, United States JobRialto Full time
Job Summary:

The Sr. Research and Development (R&D) Engineer applies engineering principles and methods to ensure compliance with regulatory requirements and Client ' systems and procedures. This role plays a key part in optimizing product development, internal and external device manufacturing, and device distribution. The engineer will focus on problem-solving, product development, testing, and documentation throughout the development lifecycle.

Key Responsibilities:
  • Develop solutions to a variety of problems of moderate scope and complexity.
  • Brainstorm, assess, and design innovative ideas for new product development.
  • Update and maintain the technical content of the risk management file.
  • Apply mechanical and biomedical engineering principles to design and develop components for the delivery system.
  • Drive design selection based on clinical impact, material, and manufacturability considerations.
  • Develop test methods and procedures to evaluate the performance of device prototypes.
  • Assign tasks to technicians, provide instructions, train them, and give feedback on test conduct; may also coordinate technician work.
  • Maintain detailed documentation for concepts, designs, drawings, and procedures.
  • Generate written protocols, reports, and technical justifications or summaries.
  • Perform other incidental duties as assigned by leadership.
Required Qualifications:
  • Proven expertise in the use of MS Office Suite.
  • Strong documentation, communication, and interpersonal relationship skills, including negotiation and relationship management.
  • Working knowledge of statistical techniques.
  • Hands-on experience with test lab equipment (if applicable).
  • Substantial understanding of engineering principles, theories, and concepts.
  • Strong problem-solving, organizational, analytical, and critical thinking skills.
  • Leadership skills with the ability to influence change.
  • Knowledge of Design Control processes.
  • Knowledge of applicable FDA regulations for the medical device industry is desirable.
  • Ability to interact professionally with all organizational levels.
  • Ability to manage competing priorities in a fast-paced environment.
  • Team-oriented with the ability to work on inter-departmental teams and as a key contact for contracts or projects.
  • Ability to engage with senior internal and external personnel on significant matters, often requiring coordination across organizations.
  • Adhere to all EHS rules and regulations, ensuring workplace safety and environmental protection.
referred Qualifications:
  • Hands-on experience with catheter design, including machining, extrusions, braiding, molding, and bonding processes.
  • Experience in new product development from concept to commercialization.
  • Experience in the medical device industry, particularly with mechanical problem-solving in medical device design.
Certifications:
  • None required.
Education/Experience:
  • Bachelor's degree in Engineering (Mechanical or Biomedical preferred) with at least 4 years of experience in the medical industry; OR
  • Master's degree or equivalent in Engineering or a related field with 3 years of relevant industry or education-related experience; OR
  • Ph.D. or equivalent in Engineering or related field, with no professional experience required.
  • Demonstrated ability to apply technical knowledge and judgment to complex technical problems in the medical device field.
  • Effective communication and collaboration skills are essential, including the ability to influence results within a cross-functional team.


Location- 17211 Redhill Ave, Irvine, CA 92614

Education: Bachelors Degree

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